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Safety and Immunogenicity of Live Influenza A Vaccine for Avian Influenza H7N7

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00922259
Recruitment Status : Completed
First Posted : June 17, 2009
Last Update Posted : February 13, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Every year the human population suffers from seasonal outbreaks of influenza resulting in both illness and death. However, the rates of illness and death from seasonal outbreaks are significantly lower than those suffered during times of influenza pandemic, such as those experienced in 1918, 1957, and 1968. The reason for this difference lies in presence of immunity within a population. With seasonal outbreaks of influenza most people have some immunity to the circulating strain and usually only those with weakened immune systems experience serious complications. Influenza pandemics, in contrast, are the result of a completely new viral subtype to which nobody possesses an immunity, leaving everyone vulnerable to the most serious of complications.

It has been estimated that the next flu pandemic could cause over 200,000 deaths and over 700,000 hospitalizations in the US alone. The need for an effective viral vaccine is high. The purpose of this study is to test the safety and immunogenicity of a live influenza A strain vaccine, which would be able to combat an influenza pandemic.


Condition or disease Intervention/treatment Phase
Influenza A Biological: Influenza A H7N7 vaccine Phase 1

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase 1 Inpatient Study of the Safety and Immunogenicity of Live Influenza A Vaccine H7N7 (6-2) AA ca Recombinant (A/Netherlands/219/03 (H7N7) x A/Ann Arbor/ 6/60 ca), a Live Attenuated Virus Vaccine Candidate for Prevention of Avian Influenza H7N7 Infection in the Event of a Pandemic
Study Start Date : July 2010
Primary Completion Date : January 2012
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: H7N7 Vaccine
Participants will be administered two doses of the candidate live influenza A H7N7 vaccine
Biological: Influenza A H7N7 vaccine
Participants will be administered two doses of the candidate vaccine at a dosage of approximately 10^7.5 50% tissue culture infectious dose (TCID50), in the form of nasal spray. The doses will be administered 28-62 days apart.


Outcome Measures

Primary Outcome Measures :
  1. Immunogenicity as measured by Anti-H7N7 antibody and seroconversion [ Time Frame: Measured on Days 2 to 9 and 26 to 37 ]
  2. Determine the frequency of vaccine-related reactogenicity events (REs) and other adverse events (AEs) for 2 doses of vaccine [ Time Frame: Measured on Days 2 to 9 and 26 to 37 ]

Secondary Outcome Measures :
  1. Frequency of vaccine-related reactogenicity events (REs) and other adverse events (AEs) for each dose [ Time Frame: Measured on Days 2 to 9 and 26 to 37 ]
  2. Area under the curve of nasal virus shedding after each dose of vaccine [ Time Frame: Measured on Days 2 to 9 and 28 to 37 ]
  3. Amount of serum and nasal wash antibody induced by the vaccine [ Time Frame: Measured through Day 208 ]
  4. Number of vaccinees infected with the H7N7 NL 2003/AA ca recombinant vaccine candidate [ Time Frame: Measured through Day 208 ]
  5. Phenotypic stability of vaccine virus shed [ Time Frame: Measured through Day 208 ]
  6. Determination of whether immunogenicity is enhanced by a second dose of vaccine, and whether the first dose of vaccine restricts replication of the second dose [ Time Frame: Measured through Day 208 ]
  7. T-cell mediated and innate immune responses against the H7N7 NL 2003/AA ca recombinant vaccine candidate [ Time Frame: Measured through Day 208 ]
  8. Development of serum antibody, as assessed by either hemagluttinin (HAI) or microneutralization (MN) assays [ Time Frame: Measured through Day 208 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Able to provide informed consent
  • General good health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator
  • Available for the duration of the trial
  • Female participants must agree to use effective birth control methods for the duration of the study. More information on this criterion can be found in the study protocol.
  • Agrees to store blood specimens for future research

Exclusion Criteria:

  • Pregnancy or breast-feeding
  • Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies including urine testing. Clinically significant ALT levels, as determined by the Principal Investigator, will be exclusionary at baseline, prior to vaccination.
  • Behavioral or cognitive impairment or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol
  • Previous enrollment in an H7 influenza vaccine trial or in any study of an avian influenza vaccine
  • Seropositive to the H7N7 influenza A virus (serum HI titer greater than 1:8)
  • Positive urine drug toxicology test indicating narcotic use or dependency
  • Have medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months
  • Other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant participating in the trial or would render the participant unable to comply with the protocol
  • History of anaphylaxis
  • Allergy to oseltamivir
  • Diagnosis of asthma or reactive airway disease within the past 2 years
  • History of Guillain-Barre Syndrome
  • Positive ELISA and confirmatory Western blot tests for HIV-1
  • Positive ELISA and confirmatory test (for example, recombinant immunoblot assay [RIBA]) for hepatitis C virus (HCV)
  • Positive test for hepatitis B virus surface antigen (HBsAg) by ELISA.
  • Known immunodeficiency syndrome
  • Use of corticosteroids (excluding topical preparations) or immunosuppressive drugs within 30 days prior to vaccination
  • Receipt of a live vaccine within 4 weeks or a killed vaccine within 2 weeks prior to study vaccination
  • History of a surgical splenectomy
  • Receipt of blood or blood-derived products (including immunoglobulin) within 6 months prior to study vaccination
  • Current smoker unwilling to stop smoking for the duration of the study. More information on this criterion can be found in the study protocol.
  • Travel to the Southern Hemisphere within 14 days prior to study vaccination.
  • Travel on a cruise ship within 14 days prior to study vaccination
  • Current involvement with the poultry industry. This refers to direct contact with poultry within the 14 days prior to the study or after the study completion.
  • Receipt of another investigational vaccine or drug within 30 days prior to study vaccination
  • Allergy to eggs or egg products
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00922259


Locations
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)
Investigators
Principal Investigator: John Treanor, MD University of Rochester
More Information

Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00922259     History of Changes
Other Study ID Numbers: URMC 10-003
First Posted: June 17, 2009    Key Record Dates
Last Update Posted: February 13, 2013
Last Verified: February 2013

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Flu
Influenza
Vaccine
Prevention

Additional relevant MeSH terms:
Influenza, Human
Influenza in Birds
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs